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Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K:重大事件
美股SEC公告 ·  2024/11/27 06:18

牛牛AI助理已提取核心訊息

Intelligent Bio Solutions has successfully completed its method comparison study for the Intelligent Fingerprinting Drug Screening System, achieving 94.1% accuracy, 82.2% sensitivity, and 100% specificity. The study, conducted with CenExel involving 135 healthy donors and nine system operators, validated the system's effectiveness for workplace drug testing applications.The study evaluated three core components: Drug Screening Cartridge, Drug Screening Reader, and Fingerprint Collection Kit, comparing fingerprint sweat opiate screening results with LC-MS/MS laboratory methods. The system demonstrated excellent usability with no usage errors reported during testing.Following these positive results and recent PK study outcomes, the company plans to submit FDA 510(k) application in Q4 2024. Upon potential FDA clearance, INBS aims to introduce its fingerprint sweat-based drug screening technology to the US market in 2025, targeting safety-critical industries including construction, mining, transportation, law enforcement, and drug rehabilitation sectors.
Intelligent Bio Solutions has successfully completed its method comparison study for the Intelligent Fingerprinting Drug Screening System, achieving 94.1% accuracy, 82.2% sensitivity, and 100% specificity. The study, conducted with CenExel involving 135 healthy donors and nine system operators, validated the system's effectiveness for workplace drug testing applications.The study evaluated three core components: Drug Screening Cartridge, Drug Screening Reader, and Fingerprint Collection Kit, comparing fingerprint sweat opiate screening results with LC-MS/MS laboratory methods. The system demonstrated excellent usability with no usage errors reported during testing.Following these positive results and recent PK study outcomes, the company plans to submit FDA 510(k) application in Q4 2024. Upon potential FDA clearance, INBS aims to introduce its fingerprint sweat-based drug screening technology to the US market in 2025, targeting safety-critical industries including construction, mining, transportation, law enforcement, and drug rehabilitation sectors.
智能生物解決方案公司成功完成了智能指紋藥物篩查系統的方法比較研究,達到了94.1%的準確率、82.2%的靈敏度和100%的特異性。該研究與CenExel合作,涉及135名健康捐贈者和九名系統操作員,驗證了該系統在工作場所藥物檢測應用中的有效性。研究評估了三個核心元件:藥物篩查 Cartridge、藥物篩查閱讀器和指紋收集套件,比對了指紋汗液鴉片篩查結果與LC-MS/MS實驗室方法。該系統在測試過程中表現出極好的可用性,沒有出現使用錯誤。在這些積極結果和最近的Pk研究結果之後,公司計劃在2024年第四季度提交FDA 510(k)申請。在潛在的FDA批准後,INBS旨在於2025年將其基於指紋汗液的藥物篩查科技引入美國市場,目標是包括施工、採礦、交通、執法和藥物康復等安全關鍵行業。
智能生物解決方案公司成功完成了智能指紋藥物篩查系統的方法比較研究,達到了94.1%的準確率、82.2%的靈敏度和100%的特異性。該研究與CenExel合作,涉及135名健康捐贈者和九名系統操作員,驗證了該系統在工作場所藥物檢測應用中的有效性。研究評估了三個核心元件:藥物篩查 Cartridge、藥物篩查閱讀器和指紋收集套件,比對了指紋汗液鴉片篩查結果與LC-MS/MS實驗室方法。該系統在測試過程中表現出極好的可用性,沒有出現使用錯誤。在這些積極結果和最近的Pk研究結果之後,公司計劃在2024年第四季度提交FDA 510(k)申請。在潛在的FDA批准後,INBS旨在於2025年將其基於指紋汗液的藥物篩查科技引入美國市場,目標是包括施工、採礦、交通、執法和藥物康復等安全關鍵行業。

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